Marcus S. Delatte, Ph.D.

Marcus S. Delatte, Ph.D.

Marcus S. Delatte, Ph.D.

Principal Consultant

Marcus has more than 22 years of experience as a researcher and regulatory toxicology professional in pharmaceutical research and development. He has provided advise for regulatory and nonclinical development programs in acute and chronic pain syndromes (includes abuse deterrent formulations), medical countermeasures (includes using the animal rule), neuropharmacology, addiction, anesthesia, inflammation, sclerosis, neurolysis, and complete life cycle management.

Work Experience

At Parexel, Marcus uses his extensive scientific, drug development, and regulatory expertise to assist clients in the negotiation of nonclinical development plans and regulatory strategies with FDA to achieve their company objectives. Marcus serves as the Technical Lead on nonclinical development programs by preparing meeting packages, attending and/or leading FDA meetings, and preparing nonclinical sections of IND/NDA submissions. Prior to joining Parexel, he was a Pharmacologist at the Food and Drug Administration. At the FDA, he managed a product portfolio that consisted of 264 IND and 30 NDA applications. He advised clients on the design of and the results from pharmacology, pharmacokinetic/toxicokinetic, safety pharmacology, general toxicology, reproductive and developmental toxicology, genetic toxicology, and carcinogenicity studies. His core functions included identifying and resolving safety issues with drug substances, metabolites, excipients, impurities, and container closure systems. Marcus has published 1 book chapter and 9 original research articles in top-tier scientific journals.

Education

Marcus holds a PhD in Pharmacology (Louisiana State University Health Sciences Center – New Orleans) and a BA in Psychology (University of New Orleans). He also completed a post-doctoral fellowship in Pharmacology at the Harvard Medical School/McLean Hospital.

We are always available for a conversation.

*